First In Human Study Of Increasing Oral Doses Of PF-04634817

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01098877

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04634817 Placebo Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Drug: PF-04634817 Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: PF-04634817 Placebo Oral solution, placebo, single dose
Experimental: Cohort 1, 1mg	Drug: PF-04634817 Oral solution, 1mg, single dose
Experimental: Cohort 1, 3mg	Drug: PF-04634817 Oral solution, 3mg, single dose
Experimental: Cohort 1, 10mg	Drug: PF-04634817 Oral solution, 10mg, single dose
Experimental: Cohort 2, 30mg	Drug: PF-04634817 Oral solution, 30mg, single dose
Experimental: Cohort 2, 100mg	Drug: PF-04634817 Oral solution, 100mg, single dose
Experimental: Cohort 2, 300mg	Drug: PF-04634817 Oral solution, 300mg, single dose
Experimental: Cohort 3, 600mg	Drug: PF-04634817 Oral solution, 600mg, single dose
Experimental: Cohort 3, 900mg	Drug: PF-04634817 Oral solution, 900mg, single dose
Experimental: Cohort 3, up to 900mg (fed)	Drug: PF-04634817 Oral solution, up to 900mg, single dose after food
Placebo Comparator: Cohort 3, placebo (fed)	Drug: PF-04634817 Placebo Oral solution, placebo, single dose after food

Outcome Measures

Primary Outcome Measures

Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests [0-3 days]
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 [0-4 days]
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr [0-2 days]
p-ERK inhibition in human monocytes [0-3 days]
Change in circulating monocytes [0-3 days]

Secondary Outcome Measures

Change from baseline in plasma MCP-1 [0-3 days]
MIP 1B stimulated CCR5 receptor internalization [0-3 days]
MCP-1 stimulated CCR5 receptor internalization [0-3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.